miroliverELAP for Acute Liver Failure

Recruiting at 9 trial locations

Overseen By M. Mason Macenski, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Miromatrix Medical Inc.

Must not be taking: Narrow therapeutic index

Disqualifiers: Chronic liver disease, Liver cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called miroliverELAP, a bioengineered liver graft, for individuals with serious liver problems. It aims to support the liver's recovery or facilitate a transplant by providing assistance for up to 48 hours. The trial targets those with sudden liver failure, severe alcohol-related liver disease, or worsening liver issues on top of chronic liver disease. Ideal participants are those in intensive care with these liver conditions who are not suitable for a liver transplant. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are on medications with a narrow therapeutic index.

What prior data suggests that miroliverELAP is safe for treating acute liver failure?

Research into miroliverELAP suggests it could be a promising treatment for sudden liver failure. However, without specific safety results from past studies, understanding a phase 1 trial is crucial.

Phase 1 trials aim to determine if the treatment is safe for people. Researchers test the treatment on humans for the first time, exercising great caution. They monitor for side effects and observe how the body responds. Since miroliverELAP is in a phase 1 study, researchers are still closely examining its safety in a small group.

If the treatment is well-tolerated with minimal side effects, it can advance to further testing. Participating in phase 1 trials is important because it helps researchers learn about the treatment's safety, a significant step in developing new options for liver failure. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for acute liver failure, which often involves supportive care or liver transplantation, miroliverELAP offers a novel approach. It acts as an extracorporeal liver support system, potentially providing temporary liver function to patients. Researchers are excited about miroliverELAP because it can bridge patients to liver recovery or transplantation by mimicking the liver's detoxifying functions. This could lead to improved outcomes and reduce the immediate need for a liver transplant.

What evidence suggests that miroliverELAP is effective for acute liver failure?

Research has shown that miroliverELAP, the treatment under study in this trial, is designed to aid liver recovery during sudden liver failure. It functions as a temporary liver support system, allowing the damaged liver time to heal or for a suitable transplant to be found. The treatment uses a specially created liver and an external blood circuit that can operate for up to 48 hours. Early results suggest this could be a promising option for individuals with liver failure, providing crucial support when the liver cannot function properly. Although human studies have provided limited data, the treatment's approach focuses on delivering essential assistance to the liver, which is vital in these situations. ^{1 2 3 5 6}

Who Is on the Research Team?

Jack Lake, MD

Principal Investigator

Miromatrix

Are You a Good Fit for This Trial?

This trial is for individuals with sudden severe liver failure not caused by long-term liver disease. Participants must be in need of support while their own liver recovers or until a transplant is available.

Inclusion Criteria

I am able to understand and agree to the study, or I have someone legally authorized to consent for me.

I am between 8 and 80 years old.

I am not eligible for a liver transplant now or if my condition worsens.

Exclusion Criteria

Underlying chronic liver disease including acute-on-chronic liver disease, acute alcoholic-associated hepatitis, cirrhosis, Grade IV West Haven Encephalopathy Criteria, previous liver transplant, currently requires chronic hemodialysis, uncontrolled documented infection, hypotension or refractory shock, liver injury due to trauma, any current liver cancer, currently on medications with a narrow therapeutic index, platelet count < 40,000 μL, subject is intubated and has an acute lung injury, experiencing a bleeding event defined as active gastrointestinal or other overt bleeding event, hemoglobin drop > 3g/dL within the past 24 hours, received ≥ 3 units of red blood cell transfusion within the past 24 hours, female that is currently pregnant, planning to be pregnant, or currently breastfeeding, refusal to receive blood products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive continuous treatment with miroliverELAP for 48 hours

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

32 days

What Are the Treatments Tested in This Trial?

Interventions

• miroliverELAP

Trial Overview The safety of miroliverELAP, an external device designed to assist the failing liver, is being tested. It combines a bioengineered liver graft and blood circuit to support patients for up to 48 hours.

How Is the Trial Designed?

Group I: miroliverELAP treatment Experimental Treatment 1 Intervention

48 hour treatment with miroliverELAP

Who Is Running the Clinical Trial?

Miromatrix Medical Inc.

Lead Sponsor

Trials

6

Recruited

200+

Published Research Related to This Trial

A study involving 70 patients who underwent adult-to-adult right-lobe living donor liver transplantation (ARL-LDLT) showed that it is a safe and effective option for patients with high MELD scores suffering from HBV-related benign liver disease.

Short-term outcomes, such as 30-day mortality and graft loss, were similar between ARL-LDLT and deceased donor liver transplantation (DDLT), indicating that high MELD scores do not necessarily prevent successful transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult-to-adult right-lobe living donor liver transplantation in recipients with hepatitis B virus-related benign liver disease and high model end-stage liver disease scores. Jiang, L., Yan, L., Tan, Y., et al.[2021]

The study successfully developed bioengineered liver (BEL) grafts using decellularized porcine liver scaffolds entirely seeded with human cells, which adhered to safety guidelines and showed improved functionality compared to grafts seeded with porcine cells.

BELs seeded with primary human liver cells (PHLCs) were more effective at clearing ammonia and maintained their function after cold storage, indicating their potential as a bridge therapy for patients with acute liver failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manufacturing and Functional Characterization of Bioengineered Liver Grafts for Extracorporeal Liver Assistance in Acute Liver Failure. Nelson, VL., Stumbras, AR., Palumbo, RN., et al.[2023]

Timely adult-to-adult living-donor liver transplantation (AALDLT) significantly improves survival rates for patients with acute liver failure (ALF), with a 1-year survival rate of 65% among recipients.

Waiting longer than 5 days for transplantation is associated with increased mortality and worse renal function in recipients, highlighting the importance of prompt intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult-to-adult living donor liver transplantation for acute liver failure in China. Yuan, D., Liu, F., Wei, YG., et al.[2021]

In a study of 22 patients with idiosyncratic drug-induced liver injury (iDILI) who underwent low-volume plasma exchange (PLEX-LV) and low-dose steroids, 59% achieved one-month transplant-free survival, indicating this treatment may be effective for patients not opting for liver transplantation.

A significant predictor of improved survival was a reduction of 25% or more in plasma von Willebrand factor (VWF) levels after PLEX-LV, suggesting that monitoring VWF could help assess treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Centre Experience With Low-Volume Plasma Exchange and Low-Dose Steroid to Treat Patients With Idiosyncratic Drug-Induced Acute Liver Failure. Singh, KA., Kumar, SE., Zachariah, UG., et al.[2023]

A study of 50 adult-to-adult living donor liver transplantations (A-A LDLT) showed that when the remnant liver volume of donors is over 35% and the graft volume to recipient standard liver volume ratio exceeds 40%, the procedure is very safe for both donors and recipients.

The 1-year survival rate for recipients was 92%, with a low donor mortality rate and manageable complication rates, indicating that A-A LDLT can be an effective treatment option for patients with severe liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical study on safety of adult-to-adult living donor liver transplantation in both donors and recipients. Liu, B., Yan, LN., Wang, WT., et al.[2019]

The AMC-bio-artificial liver (BAL) system was tested in a phase I study involving 7 patients with acute liver failure, demonstrating safety with no severe adverse events reported during treatment.

Out of the 7 patients, 6 were successfully bridged to liver transplantation, and one patient improved enough to avoid the need for a transplant, indicating the potential efficacy of the AMC-BAL system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical trial with the AMC-bioartificial liver. van de Kerkhove, MP., Di Florio, E., Scuderi, V., et al.[2019]

Hybrid bioartificial liver (BAL) support systems are being developed as a treatment for acute liver failure, as fully artificial systems have not been effective; current BAL devices are still in early stages of development.

Hollow-fiber bioreactors show the most promise for BAL devices, which aim to support patients until a liver transplant can be performed, although the risks associated with using animal-derived components are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracorporeal tissue engineered liver-assist devices. Tzanakakis, ES., Hess, DJ., Sielaff, TD., et al.[2006]

The TECA-I bioartificial liver support system (BALSS) significantly improved survival and reduced harmful plasma levels in canines with acute liver failure (ALF) after 80% liver resection, with an average survival time of 108 hours compared to only 24 hours in the control group.

BALSS treatment led to beneficial changes in liver function markers, such as decreased plasma ammonia and liver enzymes, while showing no adverse effects on immune parameters, indicating its safety and efficacy in treating ALF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental research on TECA-I bioartificial liver support system to treat canines with acute liver failure. Chen, XP., Xue, YL., Li, XJ., et al.[2019]

Liver transplantation is currently the only definitive treatment for liver failure, but it is limited by organ shortages, high costs, and the need for specialized expertise, leaving many patients without options.

Alternative cell-based liver therapies, such as bioartificial livers, liver cell injections, and tissue engineering, show promise in expanding treatment availability and improving liver function, despite facing significant challenges in research and clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver cell therapy and tissue engineering for transplantation. Vacanti, JP., Kulig, KM.[2022]

In a study involving healthy pigs with drug-overdose acute liver failure, the spheroid reservoir bioartificial liver (SRBAL) significantly improved survival rates to 83% compared to 0% for standard therapy alone and 17% for a no-cell device, highlighting its potential efficacy in treating liver failure.

The SRBAL's effectiveness was linked to its ability to detoxify ammonia and reduce intracranial pressure, suggesting that the hepatocyte spheroids within the device can prevent severe brain complications associated with acute liver failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal preclinical trial of the spheroid reservoir bioartificial liver. Glorioso, JM., Mao, SA., Rodysill, B., et al.[2022]

The bioartificial liver support system, using porcine hepatocytes, was tested on seven patients with severe acute liver failure and was found to be safe, with all patients tolerating the procedure well and surviving to receive liver transplants.

Patients showed significant improvements in neurological function, decreased intracranial pressure, and reduced plasma ammonia levels, indicating the system's efficacy in providing metabolic support during the critical period before transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bioartificial liver to treat severe acute liver failure. Rozga, J., Podesta, L., LePage, E., et al.[2019]

In a study of 94 adult-to-adult living donor liver transplantations (AALDLT), the donor complication rate was low at 7.4%, indicating a safe surgical protocol for donors aged 19 to 60 years.

The 1-year survival rate for patients was high at 95.7%, demonstrating the efficacy of AALDLT as a treatment for end-stage liver disease, regardless of the type of liver graft used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adult-to-adult living donor liver transplantation with 94 cases report]. Zhu, ZJ., Zhu, LW., Gao, W., et al.[2012]

This study presents a novel approach to creating transplantable humanized liver grafts that can provide long-term support for acute liver failure (ALF) in animal models, addressing the limitations of current liver transplantation methods.

The bioengineered liver grafts demonstrated essential liver functions, such as albumin production and urea synthesis, comparable to normal liver, suggesting they could serve as a viable temporary solution while waiting for a donor organ.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal transplantation of bioengineered humanized liver grafts supports failing liver in acute condition. Vishwakarma, SK., Bardia, A., Lakkireddy, C., et al.[2019]

Citations

1. trialx.com trialx.com/clinical-trials/listings/318041/miroliverelap-for-the-treatment-of-acute-liver-failure-a-phase-1-trial/?&radius=50

miroliverELAP® for the Treatment of Acute Liver Failure: A ... The study will assess the safety of the miroliverELAP used to support liver function in an individual experiencing ALF, severe acute alcohol-associated ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06285253

miroliverELAP® for the Treatment of Acute Liver Failure: A ... The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20571195

MiroliverELAP® For The Treatment Of Acute Liver Failure miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a ...

4. ir.unither.com ir.unither.com/~/media/Files/U/United-Therapeutics-IR/documents/press-releases/2025/2025-06-24-elap.pdf

2025-06-24-elap.pdf More information about the phase 1 study of miroliverELAP for the treatment of acute liver failure is available on clinicaltrials.gov ...

5. mountsinai.org mountsinai.org/clinical-trials/miroliverelap-for-treatment-of-acute-liver-failure-phase-1-trial

miroliverELAP® for the Treatment of Acute Liver Failure Summary: The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, ...

6. ir.unither.com ir.unither.com/press-releases/2025/06-24-2025-120019289

United Therapeutics and Intermountain Health Announce ... A phase 1 study of miroliverELAP for the treatment of acute liver failure is currently underway;1 first patient in the study underwent the ...